DeviceClearance

TxTi IBF System— 510(k) K183064

Substantially Equivalent

Innovasis, Inc.

FDA 510(k) clearance K183064 for TxTi IBF System, Substantially Equivalent on 2019-06-28. Applicant: Innovasis, Inc.. Device class: 2.

Clearance details

Applicant
Innovasis, Inc.
Product code
Code MAX
Device class
Class 2
Regulation
21 CFR 888.3080
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Salt Lake City, UT, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MAX

product code MAX
Death
13
Injury
1,305
Malfunction
2,885
Total
4,203

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K183064

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183064.

Data sourced from openFDA. This site is unofficial and independent of the FDA.